Clinical trial · Interventional
Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia
Effects of Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of accrual
Summary
Brief summary (as posted)
RATIONALE: Controlling blood sugar levels may be effective in preventing infections in patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia. PURPOSE: This randomized phase I trial is studying how well controlling blood sugar levels works in preventing infection in patients with acute myeloid leukemia or acute lymphoblastic leukemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperglycemia | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| insulin glargine recombinant | Biological | — | UNRESOLVED |
| therapeutic insulin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients with goal blood glucose 80-14 mg/dL receive the Robert Wood Johnson Hospital IV insulin infusion protocol followed by insulin glargine and insulin glulisine (Apidra™) subcutaneously for 4 weeks.
- interventionNames
- Biological: insulin glargine recombinant
- Drug: therapeutic insulin
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients with goal blood glucose \< 250 mg/dL are started on subcutaneous insulin sliding scale at the discretion of the treating physician with blood glucose monitoring and adjustment according to the insulin sliding scale.
- interventionNames
- Biological: insulin glargine recombinant
- Drug: therapeutic insulin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed acute myeloid leukemia or acute lymphoid leukemia * Newly diagnosed or relapsed disease * Undergoing induction or salvage chemotherapy treatment * Must demonstrate 2 random blood sugars of ≥ 140 mg/dL while on total parenteral nutrition (TPN) OR 2 preprandial sugars of ≥ 140 mg/dL if patient is not on TPN PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Not pregnant or nursing * Negative pregnancy test * Prior diagnosis of diabetes mellitus allowed * No known history of an allergy to insulin * No documented active infection PRIOR CONCURRENT THERAPY: * Concurrent corticosteroids allowed * No concurrent oral hypoglycemic agents
References
Publications (0)
Data not yet available